Cataract
Conditions
Brief summary
This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure.
Interventions
The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens.
DEVICEManual cataract surgery
Manual: manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation
Sponsors
Technolas Perfect Vision GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 3 month | Less or equal adverse events (e.g. retinal detachment, intraocular lens (IOL) malposition, etc.) in Laser group (pooled from all cataract grades) compared with Manual group (pooled from all cataract grades); p\<0.05 will be considered statistically significant. The primary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures. |
Countries
Czechia, India
Outcome results
None listed